Clinical Trials in the Time of COVID-19

The current SARS-CoV-2-induced coronavirus (COVID-19) pandemic has called for urgent design and implementation of clinical trials against this potentially life-threatening infection. The pandemic has also had a tremendous impact on ongoing clinical trials for all other indications. In both cases, the crisis has highlighted several limitations that currently exist and hinder the agile and pragmatic, but ethically and scientifically sound clinical-trials enterprise.

In this webinar, the panelists will begin by describing the key characteristics of COVID-19 trials, particularly with regard to trial-design features such as trial mechanics (including factorial and multi-stage designs, as well as platform trials), outcome assessment and other important methodological issues. The speakers will then provide an overview of the impact that the pandemic is having on clinical trials in several fields, including oncology and cardiology. Finally, we will discuss practical issues pertaining to trial design and conduct, including for data capture, data management, statistical analysis and patient follow-up, all of which have been affected by the current crisis.

Speakers

Marc Buyse, ScD, Chief Scientific Officer at the International Drug Development Institute (IDDI).

Marc Buyse holds a ScD in biostatistics from the Harvard School of Public Health (Boston, MA). He is the founder of the International Drug Development Institute (IDDI) and of CluePoints, two biostatistical service organizations based in the US and Europe. He is interested in clinical trial design, meta-analysis, validation of biomarkers and surrogate endpoints, statistical methods in oncology, statistical detection of errors and fraud, statistical monitoring of clinical trials, and medical data sharing (http://publicationslist.org/marc.buyse).

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Everardo Saad, MD: Medical Director at the International Drug Development Institute (IDDI)

Everado Saad has nearly 20 years of experience in Medical Oncology and clinical trial designs. He graduated in Medicine and trained in Internal Medicine in Sao Paulo and did his fellowship in Medical Oncology at the University of Texas M.D. Anderson Cancer Center, in Houston. After practicing for several years, he shifted his professional career towards education and research in Medical Oncology, and has a special interest in clinical trial methodology, the assessment of endpoints, and the development of novel therapies for cancer patients.

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